Tag Archives: FSMA

OIG: “Challenges Remain in FDA’s Inspections of Domestic Food Facilities”

A recently released Office of the Inspector General (OIG) report has found that the U.S. Food and Drug Administration (FDA) is making steady progress on its implementation of the Food Safety Modernization Act (FSMA) with specific regard to inspections of domestic food facilities, but challenges remain. In particular, the OIG found, in part, that: Although … Continue Reading

FDA Releases Training Module for Carriers Subject to the Sanitary Transportation Rule

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications … Continue Reading

FDA Publishes Proposed Rule Seeking to Extend Compliance Dates for Agricultural Water Standards

FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water … Continue Reading

FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) … Continue Reading

FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. To facilitate compliance … Continue Reading

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule. In short, the final rule establishes various food defense measures that registered facilities are … Continue Reading

FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the … Continue Reading

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its … Continue Reading

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016. As … Continue Reading

FDA Issues Guidances on Exemptions from FSMA Rules

As previously reported on this blog, the U.S. Food and Drug Administration issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA) on September 10, 2015. Prior to issuing the FSMA regulations, FDA established: A Seafood Hazard Analysis and Critical Control Point (HACCP) … Continue Reading

FSMA Funds 2017: More Green for Greens

FDA announces FSMA funds to support states’ continued implementation of the produce safety rule. The Food Safety Modernization Act (FSMA) was designed to update and strengthen FDA’s risk-based approach to the oversight of food safety.  The produce safety rule – which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits … Continue Reading

FDA Launches Accredited Third-Party Certification Website

As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such … Continue Reading

FDA Slated to Extend Compliance Dates for Agricultural Water Standards

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the … Continue Reading

Questions (and Answers) on FSVP

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on … Continue Reading

FDA Issues New Guidance on FSMA’s FSVP Rule

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule. The May 30th … Continue Reading

U.S. FDA Recognizes Australia as Having a Comparable Food Safety System

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to one another. This follows FDA’s decision to recognize New Zealand and Canada as comparable foreign food safety systems in 2012 and 2016, … Continue Reading

FDA Announces Three Waivers to Sanitary Transportation Rule

By way of background, on April 5, 2016, FDA released a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for … Continue Reading

FDA May Simplify Produce Safety Rule’s Agricultural Water Standards

By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act establishes two sets of criteria for microbial water quality based on the presence of generic coli, which can indicate the presence of fecal contamination. The first does not allow any detectable generic E. coli in agricultural water for certain uses, such as water … Continue Reading

Food & Beverage Alliance Asks FDA to Extend PCHF and FSVP Compliance Dates

An alliance of 17 food and beverage trade groups has asked the Food and Drug Administration (FDA) to extend the compliance dates for supplier verification under the Preventive Controls for Human Food (PCHF) and the Foreign Supplier Verification Program (FSVP) final rules, and to align the compliance dates of the two rules. The PCHF and … Continue Reading

FDA Releases Draft Guidance to Help Sprout Operations Comply with Produce Safety Rule

By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act implemented new requirements applicable to sprout operations.  Sprouts present a unique risk because the conditions under which they are typically produced are also ideal for the growth of bacteria that cause foodborne illnesses.  FDA reports that between 1996 and July 2016 … Continue Reading

FDA Finalizes FSMA Third-Party Certification User Fee Program

As previously covered on this blog, in November 2015, the FDA announced a final rule regarding the “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” which established a voluntary program to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  As our … Continue Reading

FDA Issues Guidance for Industry on Model Accreditation Standards for Third-Party Certification Bodies

As previously covered on this blog, in November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food … Continue Reading

FSMA Update: FDA Issues Final Guidance for Voluntary Qualified Importer Program

The FDA has released final industry guidance to support compliance with its Voluntary Qualified Importer Program. The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) required FDA to establish a voluntary, fee-based program called the Voluntary Qualified Importer Program.  This program aims to facilitate the expedited review and importation of foods from importers who achieve … Continue Reading
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